FDA Approval for Implants Is Too Slow. Or Is It Too Fast?

By Paul EngApril 20, 2011

The U.S. Food and Drug Administration can’t seem to catch a break. Last week, the federal agency came under fire by the Government Accountability Office for its 510(k) program, which expedites approvals of new medical devices without requiring extensive clinical studies.

But implant makers say that the FDA still isn’t moving quickly enough when it comes to approving new medical devices. And if the FDA clamps down on approvals, new devices–and the medical jobs tied to those inventions–could move to countries with lighter regulatory rules.

Still, the GAO was pretty clear in its criticism of the FDA’s so-called 501(k) program, which allows companies to market new devices and implants as safe if they can prove the new products are similar to existing models. Last week, Marcia Crosse, director of the GAO’s healthcare team, told the Senate Special Committee on Aging:

Concerns persist about the effectiveness of the 510(k) process in general, including its ability to provide adequate assurance that devices are safe and effective. Gaps in FDA’s postmarket surveillance show that unsafe and ineffective devices may continue to be used, despite being recalled.

Since 2009, the FDA approved under the 510(k) rules at least 67 devices–including an artificial hip that was recalled last year by Johnson & Johnson after studies showed the device left metal shards in 1 out of 8 recipients.